OINDP Clinical Development
Preparing your new intranasal or inhaled drug product for clinical trials can have a major impact on its overall development timeline. Oversights in the early stages of development can derail progress of even the most promising OINDPs. Nanopharm’s dedication to developing inhaled and intranasal drug products has equipped it with the complete capabilities to progress your product through clinical stages—now fully supported by Aptar Pharma’s in-house manufacturing and fill-finish services at our Boonton, New Jersey facility.
Nanopharm Clinical Development Services
Nanopharm has the know-how, network, and capabilities to take OINDP products to the clinic. Our analytical team of respiratory specialists develops and qualifies OINDP analytical test methods, provides phase-appropriate validation in our cGMP laboratories, and tests your OINDP batch for release into the clinic. With Aptar Pharma’s recent acquisition of Mod3 Pharma’s clinical trial materials manufacturing capabilities, we now offer in-house cGMP fill and finish services for Phase 1 and Phase 2 clinical trials—eliminating the need to coordinate with external CMOs. This integration enables faster timelines and seamless execution using Aptar’s proprietary intranasal and inhaled drug delivery systems.
Nanopharm now leverages Aptar Pharma’s FDA-inspected, state-of-the-art Boonton facility to manufacture intranasal and inhaled drug product clinical trial materials (CTM) for early-phase studies. The site includes cGMP cleanrooms, high-potency API suites, biologics capabilities, and advanced fill-finish technologies—all operated in-house to ensure quality, speed, and alignment with Aptar’s drug delivery solutions.
Nanopharm’s analytical release and stability testing is exclusively focused on inhaled and intranasal drug products, utilizing a wide array of specialized analytical techniques in our cGMP-qualified laboratory.
As drug products progress through clinical trials, accurate and compliant labelling is essential for both open-label and blinded studies. At Aptar Boonton, we’ve developed robust in-house procedures for labelling clinical supplies—eliminating delays and reducing reliance on external vendors. Our integrated approach allows us to deliver properly labelled supplies directly from our facility, accelerating your development timeline and ensuring regulatory compliance.
Nanopharm makes clinical trial materials (CTM) manufacturing simple for customers through our long-standing partnerships with CMOs that specialize in small scale cGMP manufacturing of OINDPs. Nanopharm leverages its trusted relationships with the qualified CMOs so you don’t have to contract and manage another third party. We manage the technical transfer process of products Nanopharm has developed, and support oversight of the manufacturing process for a smooth and timely production process. Our CMO partners can provide manufacturing services for a range of device and formulation types, whether they are traditional small molecule or sensitive biologics. From dry powder inhalers (DPIs), pressurized metered-dose inhalers (pMDIs), nasal sprays to nebulizers, Nanopharm can deliver CTM manufacturing services that deliver with agility and speed for early phase cGMP studies.
Nanopharm’s analytical laboratory provides cGMP release and stability testing for intranasal and inhaled drug products. Our analytical laboratories develop specialized test methods specifically for our customer products from the earliest stages of development, and then perform stage appropriate qualifications and validations. Nanopharm’s analytical cGMP laboratory can perform efficient OINDP testing for clinical trial materials and perform accelerated or long-term stability testing. Customers requiring release testing and stability testing at late stage clinical or even commercial stages can rely on Nanopharm’s OINDP analytical experts.
Nanopharm cGMP Analytical Release and Stability Testing Solutions
Nanopharm’s specialized clinical development services prepare your latest OINDP product for the clinic. We can engage and manage qualified CMO partner organizations to efficiently produce your early phase cGMP clinical trial materials (CTMs) so you don’t need to seek manufacturers on your own and potentially find yourself in long queues. Our cGMP laboratories can provide stage appropriate analytical method validations and testing services for both CTM release and stability programs so you can advance your OINDPs faster and with confidence.
